Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2026-02-21 @ 6:24 AM
Study NCT ID:
NCT02499692
Status:
COMPLETED
Last Update Posted:
2020-09-16
First Post:
2015-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
SYNERGY China: Assess SYNERGY Stent in China
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hanyl@medmail.com.cn', 'phone': '02428851876', 'title': 'Dr Hanyaling', 'organization': 'The General Hospital of ShenYang Military'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'SYNERGYTM Coronary Stent System', 'description': 'Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System\n\nSYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System', 'otherNumAtRisk': 103, 'otherNumAffected': 7, 'seriousNumAtRisk': 103, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Cardiac disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders'}, {'term': 'General disorders and administration site conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders'}], 'seriousEvents': [{'term': 'Metabolism and nutrition disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 103, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Technical Success Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SYNERGYTM Coronary Stent System', 'description': 'Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System\n\nSYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System'}], 'classes': [{'categories': [{'measurements': [{'value': '98.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 day', 'description': 'Technical success rate, defined as successful delivery and deployment of the study stent to the target lesion, without balloon rupture or stent embolization, and post-procedure diameter stenosis of \\<30% assessed in 2 near-orthogonal projections with TIMI 3 flow in the target lesion, as visually assessed by the physician', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Target Lesion Revascularization (TLR) Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SYNERGYTM Coronary Stent System', 'description': 'Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System\n\nSYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Target Lesion Failure (TLF) Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SYNERGYTM Coronary Stent System', 'description': 'Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System\n\nSYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Target Vessel Revascularization (TVR) Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SYNERGYTM Coronary Stent System', 'description': 'Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System\n\nSYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Target Vessel Failure (TVF) Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SYNERGYTM Coronary Stent System', 'description': 'Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System\n\nSYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Myocardial Infarction (MI, Q-wave and Non-Q-wave) Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'SYNERGYTM Coronary Stent System', 'description': 'Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System\n\nSYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SYNERGYTM Coronary Stent System', 'description': 'Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System\n\nSYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'SYNERGYTM Coronary Stent System', 'description': 'Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System\n\nSYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.92', 'spread': '8.74', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '72', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 103}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-31', 'studyFirstSubmitDate': '2015-04-30', 'resultsFirstSubmitDate': '2015-12-11', 'studyFirstSubmitQcDate': '2015-07-15', 'lastUpdatePostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-12-11', 'studyFirstPostDateStruct': {'date': '2015-07-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-01-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Technical Success Rate', 'timeFrame': '1 day', 'description': 'Technical success rate, defined as successful delivery and deployment of the study stent to the target lesion, without balloon rupture or stent embolization, and post-procedure diameter stenosis of \\<30% assessed in 2 near-orthogonal projections with TIMI 3 flow in the target lesion, as visually assessed by the physician'}], 'secondaryOutcomes': [{'measure': 'Target Lesion Revascularization (TLR) Rate', 'timeFrame': '30 days'}, {'measure': 'Target Lesion Failure (TLF) Rate', 'timeFrame': '30 days'}, {'measure': 'Target Vessel Revascularization (TVR) Rate', 'timeFrame': '30 days'}, {'measure': 'Target Vessel Failure (TVF) Rate', 'timeFrame': '30 days'}, {'measure': 'Myocardial Infarction (MI, Q-wave and Non-Q-wave) Rate', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': 'Prospective, multicenter, single-arm study, enroll 100 patients in no more than 10 sites across China, the primary endpoint is Technical success.', 'detailedDescription': 'The study is To evaluate clinical and peri-procedural angiographic outcomes for the SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System in the treatment of subjects with atherosclerotic lesion(s) ≤34 mm in length (by visual estimate) in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter (by visual estimate).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. Subject must be at least 18 -75 years of age\n2. Subject is eligible for percutaneous coronary intervention (PCI)\n3. Target lesion(s) must be located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥2.25 mm and ≤4.0 mm, length must be ≤34\\* mm (by visual estimate), Target lesion(s) must have visually estimated stenosis ≥50% and \\<100% with thrombolysis in Myocardial Infarction (TIMI) flow \\>1\n\nKey Exclusion Criteria:\n\n1. Planned PCI (including staged procedures) or CABG after the index procedure\n2. Subject with out of range complete blood count (CBC) values that are determined by the study physician to be clinically significant.\n3. Subject is on dialysis or has baseline serum creatinine level \\>2.0 mg/dL (177µmol/L)\n4. Planned treatment of more than 3 lesions, Planned treatment of lesions in more than 2 major epicardial vessels, Planned treatment of a single lesion with more than 1 stent\n5. Target lesion(s) is located within 3 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCx) coronary artery by visual estimate.\n6. Target vessel develops a dissection greater than National Heart, Lung, Blood Institute (NHLBI) type C following the pre-dilatation/pre-treatment of the first target lesion'}, 'identificationModule': {'nctId': 'NCT02499692', 'briefTitle': 'SYNERGY China: Assess SYNERGY Stent in China', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'SYNERGY China: A Prospective, Multicenter Trial to Assess the SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System for the Treatment of Atherosclerotic Lesion(s)', 'orgStudyIdInfo': {'id': 'S2342'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SYNERGYTM Coronary Stent System', 'description': 'Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System', 'interventionNames': ['Device: SYNERGYTM Coronary Stent System']}], 'interventions': [{'name': 'SYNERGYTM Coronary Stent System', 'type': 'DEVICE', 'description': 'SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System', 'armGroupLabels': ['SYNERGYTM Coronary Stent System']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'AeroSpace center hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Changcun', 'country': 'China', 'facility': 'the second hospital of Jilin Unversity', 'geoPoint': {'lat': 38.89176, 'lon': 116.3561}}, {'city': 'Daqing', 'country': 'China', 'facility': 'Daqing General Oil Field Hospital', 'geoPoint': {'lat': 46.58333, 'lon': 125.0}}, {'city': 'Hangzhou', 'country': 'China', 'facility': 'Sir Run Run Shaw Hospital of Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Lanzhou', 'country': 'China', 'facility': 'The First Hospital of Lanzhou University', 'geoPoint': {'lat': 36.05701, 'lon': 103.83987}}, {'city': 'Shenyang', 'country': 'China', 'facility': 'General Hospital of SY Military Institute', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Tianjin', 'country': 'China', 'facility': 'TEDA International Cardiovascular Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Wuhan', 'country': 'China', 'facility': 'Wuhan Asia Heart Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'overallOfficials': [{'name': 'Yalin Han', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shenyang Northern Hospital (The General Hospital of Shenyang Military Region)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}